Prospective Randomized Clinical Trial of HEMOPATCH Topical Sealant in Cardiac Surgery

Abstract:

Objective: Hemostasis is a critical component of all surgical procedures and especially cardiac surgery. In addition to traditional means, topical hemostatic agents have been reported to be extremely effective in terminating bleeding during cardiac procedures. We compared a hemostatic matrix sealant agent (HEMOPATCH Baxter Healthcare Corporation, Deerfield, IL) with alternative topical hemostatic treatment in patients undergoing ascending aorta surgery with moderate bleeding. Materials and Methods: Following sample size calculation, in a prospective randomized study design, 85 patients were treated with HEMOPATCH matrix sealant and 85 patients received alternative treatment (dry or wet gauze compression or similar [control group]). The primary outcome measure was the percentage of patients with successful hemostasis within three minutes of HEMOPATCH or traditional treatment application. Other study outcome measures were postoperative blood loss and the rate of transfusion of blood products. Results: A statistically higher rate of successful hemostasis within three minutes was observed in the HEMOPATCH group (97.6% [83/85] vs. 65.8% [56/85] in the control group; p<0.001). The percentages of patients with postoperative bleeding and the rate of transfusion were lower in the HEMOPATCH group than in the control group. Conclusions: The use of HEMOPATCH is effective in terminating bleeding in patients undergoing ascending aorta cardiac procedures. Fewer patients treated with HEMOPATCH required blood transfusion. The cost-utility profile of HEMOPATCH should be addressed in dedicated trials.

Authors:

Luca Weltert, MD, Cardiac Surgeon, Heart Surgery Division, Salvatore D'Aleo, MD, Cardiac Surgeon, Heart Surgery Division, European Hospital, Rome, Italy, Ilaria Chirichilli, MD, Cardiac Surgeon, Heart Surgery Division, Mauro Falco, MD, Anaesthesiologist, Anesthesiology Division, Franco Turani, MD, Anaesthesiologist, Anesthesiology Division, Alessandro Bellisario, MD, Cardiac Surgeon, Heart Surgery Division, Ruggero De Paulis, MD, Cardiac Surgeon, Heart Surgery Division, European Hospital, Rome, Italy

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Accuracy of Intravascular Ultrasound Evaluation for the Assessment of Native Valve Measures in Patients Undergoing TAVI: Preliminary Results

Abstract:

Introduction: Transcatheter aortic valve implantation (TAVI) technique represents a real revolution in the field of interventional cardiology and medicine, in particular for the treatment of severe aortic valve stenosis in elderly patients or in patients when the periprocedural risk for the traditional surgical option is considered too high, as an alternative to the traditional aortic valve replacement. Although experience on the valves of the last generation is still limited in terms of time, the data currently available are definitely moving in the direction of a minimum hospital mortality (1%) as well as a drastic reduction in the incidence of complications when compared to the devices of the previous generation. Finally, the evolution of specified materials of the newest generation have greatly enhanced safety and efficacy of TAVI procedures in the last years. In order to ensure the selection of the most appropriate valve and the success of the procedure, the role of cardiac imaging (computed tomography scan evaluation and angiography) is crucial. These examinations require the use of contrast medium in patients suffering from renal dysfunction at the baseline. The need for fluoroscopy and angiography using contrast agents to aid positioning of the valve may lead to contrast-induced nephropathy (CIN) as one form or one etiology of acute kidney injury (AKI), which is associated with increased morbidity and mortality. The aim of our study is to investigate the accuracy of intravascular ultrasound (IVUS—a technique which does not need contrast) for the assessment of native valve measures in patients undergoing TAVI by comparing values obtained with IVUS to those ones previously obtained in the same patients with computed tomography (CT) scans. Material and Methods: We enrolled 25 consecutive patients (10 males, average age 81.3±5,1 years) who underwent TAVI with femoral access in our Cardiac Surgery Cath-Lab (University of Bari) from January to October 2015 (Logistic EuroSCORE 21.6±15.4%; STS score mortality 20.9±14.9%). Each patient scheduled for TAVI underwent coronary angiography and high resolution angio-CT in order to obtain a complete evaluation (diameters, perimeters, and areas at annulus level, -3mm level, +15mm level, height of coronary ostia, shape, and conformation of left ventricle outflow tract, conformation, and calcifications of aortic and ileo-femoral axis) to choose the most suitable prosthetic aortic valve for each patient. In all patients, during the procedure (before the prosthetic valve implantation), we executed a manual IVUS pullback (from left ventricle outflow tract to ascending aorta) by using a 7F IVUS probe (Volcano Corporation, San Diego, CA). On the recorded IVUS pullback, a second operator (who did not know the values obtained by CT measurements) identified the aortic annulus and, at this level, measured: minimum and maximum diameter; perimeter; derived perimeter, and area. The t-student test has been used to compare the averages of these IVUS values to the CT ones. A p value<0.05 was considered as statistically significant. Results: Independently from the kind and size of implanted prosthetic valve, no statistical differences were found when the averages of all considered parameters (obtained both with CT and IVUS) were compared. The following are the results obtained: minimum diameter (CT: 19,62mm±1,10 vs. IVUS: 19,55mm±1,40; p=0.41); maximum diameter (CT: 24,73mm±2,42 vs. IVUS: 25,9mm±1,80; p=0.08); perimeter (CT: 72,05mm±4,36 vs. IVUS: 73,32mm±6,09; p=0.164); derived perimeter (CT: 22,94mm±1,40 vs. IVUS: 23,32mm ± 1,95; p=0,198); and area (CT: 3,99cm2 ±0,97 vs. IVUS: 4,06 cm2 ± 0,47; p=0,073) (Figs. 1-3). Conclusions: These preliminary data suggest accurate IVUS measures when compared to CT in the evaluation of valve parameters considered (minimum and maximum diameters, area, perimeter, and derived perimeter at the annulus level). In order to confirm these findings and to give them statistical significance, it will be necessary to increase the sample size.

Authors:

Emanuela de Cillis, MD, PhD, Interventional Cardiologist, Annamaria Dachille, MD, Fellow of Interventional Cardiology, Francesco Giardinelli, MD, Fellow of Interventional Cardiology, Tommaso Acquaviva, MD, Chief of the Echocardiography Core Laboratory, Alessandro Santo Bortone, MD, PhD, FESC, FAHA, Chief of Interventional Cath Laboratory, Institute of Cardiac Surgery, University of Bari, Bari, Italy

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Thickness of Cadaveric Human Lung Tissue

Abstract:

Background: Choosing the correct surgical staple height is dependent on knowledge of specific tissue thickness and compressibility. The purpose of this study was to measure the thickness of cadaveric human lung tissue. Materials and Methods: Between December 2012 and February 2013, whole lungs were procured from 12 donors. Inclusion criteria included negative serology, no prior thoracic surgery, and completion of measurements within 72 hours of death. Tissue thickness was measured in the anterior-to-posterior direction using a tissue measuring device (TMD) at 41 lung locations. The tissue measuring device applied a constant pressure (8 g/mm2) via a plunger for 15 seconds before reading the thickness. Results: Cadaveric lung tissue thickness displayed a large variation by location and within each location. Mean thickness in the anterior-to-posterior direction ranged from 1.5 mm (right middle lobe [inferior peripheral] location) to 9.0 mm (right inferior lobe [mid-central] location). In general, the periphery of the lung lobes was thinner than the central locations (e.g., mean peripheral location thickness: 4.1 mm; mean central location thickness: 5.9 mm). The thinnest tissues among the 12 donor cadaveric lung specimens were found in the one donor with a history of severe emphysema/chronic bronchitis. Height (P = 0.012) and weight (P = 0.036) were positively correlated with tissue thickness. Additionally, after adjusting for height, cadaveric lung tissue was 3.0 mm thicker for females than males. Conclusions: Large variations of lung tissue thickness were demonstrated throughout the lung as well as within each measured location across different cadaveric specimens. Generally, peripheral locations were thinner than the central locations of the lobes. There was a strong positive correlation between thickness and height, and females had slightly thicker lung tissue than males of the same height.

Authors:

Edward G. Chekan, MD, FACS, Medical Director, Worldwide Medical & Clinical Affairs, Teleflex, Inc., Morrisville, NC, John F. Cummings, PhD, Research Fellow, Preclinical Research, Ethicon, Inc., Cincinnati, OH, Isaac Mabe, MS, Research Associate, Research and Development, Community Tissue Services, Inc., Kettering, OH, Shawn Hunter, PhD, Director, Research and Development, Community Tissue Services, Inc., Kettering, OH, Jeffrey W. Clymer, PhD, Biostatistician, Preclinical Research, Ethicon, Inc., Cincinnati, OH

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The Use of Energy in VATS Lobectomy

Abstract:

VATS lobectomy is a safe and effective treatment strategy for operable stage I and II lung cancer. It has a similar five-year survival compared to open lobectomy (thoracotomy). VATS lobectomy is associated with less postoperative complications and shorter hospital length of stay when compared to lobectomy by thoracotomy. VATS lobectomy has not been widely adopted by the thoracic surgical community, in part, due to technical reasons. Pulmonary artery branch manipulation in VATS lobectomy is one of the most critical parts of the procedure, especially when endostaplers are used for ligation and division of the vessel. Energy devices have improved in recent years, and their application for VATS lobectomy is gaining traction. There is more and more evidence supporting the safety of ultrasonic shears to seal and divide small pulmonary artery branches. These devices are smaller and finer than endostaplers and have the potential to reduce the risk of PA injury. These more user-friendly devices may enable thoracic surgeons who are currently performing lobectomy by thoracotomy to transition to VATS. Energy devices are also useful for hilar dissection and mediastinal lymph node dissection in VATS lobectomy.

Authors:

Eric Goudie, MD, Surgery Resident, University of Montreal, Research Fellow, Centre de Recherche du CHUM, CHUM Endoscopic Tracheobronchial and Oesophageal Center (CETOC), Centre Hospitalier de l'Université de Montréal, Montreal, Canada, Mehdi Tahiri, MD, MSc, Surgery Resident, McGill University, CHUM Endoscopic Tracheobronchial and Oesophageal Center (CETOC), Centre Hospitalier de l'Université de Montréal, Montreal, Canada, Moishe Liberman, MD, PhD, Associate Professor, Department of Surgery, Division of Thoracic Surgery, University of Montreal, CHUM Endoscopic Tracheobronchial and Oesophageal Center (CETOC), Centre Hospitalier de l'Université de Montréal, Montreal, Canada

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Fenestrated Endografts for Complex Abdominal Aortic Aneurysm Repair

Abstract:

Since the introduction of fenestrated endovascular aneurysm repair (FEVAR) in 1996, great advances have been made in endograft development. Custom-made and off-the-shelf fenestrated and branched endografts have been used to treat patients with complex abdominal aortic and thoraco-abdominal aneurysms. Most experience has been gained with the Cook Zenith® fenestrated endograft (Cook Medical Inc., Limerick, Ireland). The Cook Zenith® endograft is customized with fenestrations, (fixed) inner or outer branches, or a combination of them, to cover a wide range of complex aneurysms. There are limitations to the number, location, and size of the fenestrations and to the maximal angulation of the aorta. Because the production of a custom-made fenestrated endograft takes several weeks, and is therefore not available for emergency cases, off-the-shelf fenestrated endograft were developed. One of these grafts was the Endologix Ventana™ (Endologix, Inc., Irvine, California). This endograft was withdrawn from enrollment due to a high reintervention rate. Vascutek Ltd. developed the custom-made Vascutek Fenestrated Anaconda™ endograft (Vascutek Ltd., Inchinnan, Scotland) to treat patients where other endografts were not suitable—like in a more tortuous aorta with an angulation up to 90°. Additionally, the unsupported proximal body enables a high number and large size of fenestrations if needed. First reports of custom-made fenestrated and (inner and outer) branched JOTEC E-xtra DESIGN ENGINEERING (JOTEC GmbH, Hechingen, Germany) for aortic aneurysms seem promising, but larger series need to be reported to be able to draw conclusions. Both custom-made Cook Zenith® and Vascutek Fenestrated Anaconda™ endografts have good reported clinical outcomes with a perioperative mortality between 4.1 and 6.7% and a reintervention rate of <10% at one year. Knowledge on the long-term outcome of both devices is still limited.

Authors:

Arne de Niet, MD, PhD Candidate, Surgical Resident, Department of Surgery, Division of Vascular Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands, Michel MPJ Reijnen, MD, PhD, Consultant Vascular Surgeon, Department of Vascular Surgery, Rijnstate Hospital, Arnhem, The Netherlands, Ignace FJ Tielliu, MD, PhD, Consultant Vascular Surgeon, Department of Surgery, Division of Vascular Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands, Jan Willem HP Lardenoije, MD, PhD, Consultant Vascular Surgeon, Department of Vascular Surgery, Rijnstate Hospital, Arnhem, The Netherlands, Clark J Zeebregts, MD, PhD, Consultant Vascular Surgery, Professor of Vascular Surgery, Department of Surgery, Division of Vascular Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

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